Healthy SubjectsPhase 2NCT01443507
Effect of Exercise With Low Intensity and Longer Duration Versus High Intensity Interval Training
A Phase 2 study testing endurance exercise of different duration and intensity in people with Healthy Subjects, run by Volda University College at 1 site in Norway.
Trial summary
The purpose of the study is to compare exercise at 70% of maximal heart rate were total energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- endurance exercise of different duration and intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy non smoking men and woman, age 18-30
Who cannot join
- pathological findings measured by ekko/doppler, high cholesterol or high blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Endurance Exercise With Low Intensity and Longer Duration Improve Aerobic Capacity to the Same Extent as High Intensity Interval Training?
The purpose of the study is to compare exercise at 70% of maximal heart rate were total energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate. Since 70% of maximal heart rate is well above the minimum threshold for improvements in maximal oxygen uptake it should be suited to investigate the effect of duration.
- Conditions
- Healthy Subjects
- Being tested
- endurance exercise of different duration and intensity
- Keywords
- aerobic capacity, maximal oxygen uptake, aerobic endurance, work economy, lactate threshold, endurance training, exercise intensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endurance exercise of different duration and intensityOther
Two interventions are compared with aerobic capacity as the main outcome. one group exercise at 70% of maximal heart rate for 90 minutes 3 times per week. group two exercise performe10 minutes warm up at 70% of maximal heart rate 4 x 4 minutes intervals at 90-95% of maximal heart rate with 3 minutes active pause at 70% of maximal heart rate in between, and finally 5 minutes cooling down at 70 % of maximal heart rate.
| Study group | Role | What they receive |
|---|---|---|
| high intensity long interval | Experimental | A group training four by four minutes interval at 90-95% of maximal heart rate dispersed by three minutes active pauses at 70% of maximal heart rate. Receives: Other: endurance exercise of different duration and intensity |
| long duration at moderate training | Experimental | a continuous training group exercising at 70% of maximal heart rate for 90 minutes. Receives: Other: endurance exercise of different duration and intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in maximal oxygen uptake
Measured: Maximal oxygen uptake will be measured at day 1 before training, then we will measure changes in maximal oxygen uptake after 8 weeks, and finally a follow up measurement of changes in maximal oxygen uptake after 1 year
Secondary outcomes (2)
endurance performance
work economy, lactate threshold will be measured toghether with maximal oxygen uptake to determine endurance performance.
Measured: one year
health effects
coronary flow reserve, blood pressure, maximal oxygen uptake
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volda University College
- Sponsor type
- University, hospital or other
- Collaborators
- helse Møre og Romsdal, Volda sjukehus
- Responsible party
- Principal investigator, Kjetil Laurits Hoydal, Volda University College
- Investigators
- Aud Folkestad, dean, Study director, Volda University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443507
- Sponsor's protocol ID
- 2010/2959
- Status last verified
- Dec 2014
- First submitted
- 21 Sep 2011
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Endurance Exercise With Low Intensity and Longer Duration Improve Aerobic Capacity to the Same Extent as High Intensity Interval Training?
- ClinicalTrials.gov ID
- NCT01443507
- Acronym / sponsor ID
- 2010/2959
- Conditions
- Healthy Subjects
- Keywords
- aerobic capacity, maximal oxygen uptake, aerobic endurance, work economy, lactate threshold, endurance training, exercise intensity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Volda University CollegeUniversity, hospital or other
- Collaborators
- helse Møre og Romsdal, Volda sjukehus
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare exercise at 70% of maximal heart rate were total energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate. Since 70% of maximal heart rate is well above the minimum threshold for improvements in maximal oxygen uptake it should be suited to investigate the effect of duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high intensity long interval | Experimental | Other: endurance exercise of different duration and intensityA group training four by four minutes interval at 90-95% of maximal heart rate dispersed by three minutes active pauses at 70% of maximal heart rate. |
| long duration at moderate training | Experimental | Other: endurance exercise of different duration and intensitya continuous training group exercising at 70% of maximal heart rate for 90 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy non smoking men and woman, age 18-30
Key exclusion criteria (1 listed)
- pathological findings measured by ekko/doppler, high cholesterol or high blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endurance exercise of different duration and intensityTwo interventions are compared with aerobic capacity as the main outcome. one group exercise at 70% of maximal heart rate for 90 minutes 3 times per week. group two exercise performe10 minutes warm up at 70% of maximal heart rate 4 x 4 minutes intervals at 90-95% of maximal heart rate with 3 minutes active pause at 70% of maximal heart rate in between, and finally 5 minutes cooling down at 70 % of maximal heart rate. | Other | high intensity long interval, long duration at moderate training |
Primary outcome
changes in maximal oxygen uptake
Time frame: Maximal oxygen uptake will be measured at day 1 before training, then we will measure changes in maximal oxygen uptake after 8 weeks, and finally a follow up measurement of changes in maximal oxygen uptake after 1 year
2 secondary outcomes
endurance performance
Time frame: one year
health effects
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aud Folkestad, dean study director
Volda University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing endurance exercise of different duration and intensity in people with Healthy Subjects, run by Volda University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in maximal oxygen uptake (time frame: Maximal oxygen uptake will be measured at day 1 before training, then we will measure changes in maximal oxygen uptake after 8 weeks, and finally a follow up measurement of changes in maximal oxygen uptake after 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.